A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01636362
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : September 5, 2014
Last Update Posted : October 7, 2014
Information provided by (Responsible Party):
Molnlycke Health Care AB

Brief Summary:
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.

Condition or disease Intervention/treatment Phase
Burns Wound Healing Device: Mepitel Ag Not Applicable

Detailed Description:
see Brief summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mepitel Ag
Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Device: Mepitel Ag
Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.

Primary Outcome Measures :
  1. Number of Subjects Healed at Day 14. [ Time Frame: Healing will be assessed after 14 days. ]
    > = 95 % epitheliazation

  2. Proportion of Subjects Healed at Day 21. [ Time Frame: Healing will be assessed after 21 days. ]
    The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.

Secondary Outcome Measures :
  1. Percent of Study Burn Healed. [ Time Frame: At day 21 ]
    Percent of study burn healed measured by PictZar photo analysis of tissue types.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
  • Study site is from 1-15% BSA
  • Study site is a single, isolated burn area
  • From 2 years and above
  • Thermal burn injury
  • Signed Informed Consent/Assent Form
  • Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.

Exclusion Criteria:

  • Completely non-exuding or dry wound bed at study site
  • Full thickness >5%
  • Burn greater than 24 hrs old
  • Burns to face or neck
  • Suspicion of infection of study burn
  • Use of chemical/enzymatic and biological debridement within 7 days of investigation start
  • Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
  • Subject with lung injury or subject being on a ventilator
  • Subject with dermatologic skin disorders or necrotizing processes
  • Subject with insulin dependent diabetes mellitus
  • Electrical, chemical etiology
  • Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
  • Non-compliant subject
  • Subject previously included in this investigation
  • Subject included in other ongoing clinical investigation at present or during the past 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01636362

United States, Arizona
Arizona Burn Center
Phoenix, Arizona, United States, 85008
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Oklahoma
Paul Silverstein, MD
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
S:t Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Molnlycke Health Care AB
Principal Investigator: Paul Silverstein, MD INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center

Responsible Party: Molnlycke Health Care AB Identifier: NCT01636362     History of Changes
Other Study ID Numbers: MpT Ag 01
First Posted: July 10, 2012    Key Record Dates
Results First Posted: September 5, 2014
Last Update Posted: October 7, 2014
Last Verified: December 2013

Keywords provided by Molnlycke Health Care AB:
Partial-thickness second degree burns
Mepitel Ag
Silver dressing

Additional relevant MeSH terms:
Wounds and Injuries